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tv   Key Capitol Hill Hearings  CSPAN  November 12, 2013 2:00pm-3:01pm EST

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convinced of that. >> here on c-span2 the u.s. senate gaveling in next to take up the nomination of a judge for the u.s. circuit court of appeals also debate and action later today on an fda bill. live coverage on c-span2. the chaplain: let us pray. our father, we wait in reverence before your throne. cleanse us from our sins, creating in us clean hearts while renewing a right spirit within us. lord, help our lawmakers today to discern your voice and do your will. give them the ability to
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differentiate your guidance from all others, permitting you to lead them to your desired destination. speak to them through your word, guide them with your spirit, and sustain them with your might. let all they do be well done, fit for your eyes to see, and receiving your divine approbation. and, lord, we ask you to comfort senator and mrs. inhofe, as they grieve the death of their son. we pray in your merciful name. amen.
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the president pro tempore: please join me in reciting the pledge of allegiance to the flag. i pledge allegiance to the flag of the united states of america and to the republic for which it stands, one nation under god, indivisible, with liberty and justice for all. mr. reid: mr. president? the presiding officer: the majority leader. mr. reid: i move to proceed to calendar number 236, the drug compounding legislation. the president pro tempore: the clerk will report. the clerk: h.r. 3204, a an act to amend the federal food, drug, and cosmetic act with respect to human drug compounding and drug supply chain security, and for other purposes. mr. reid: mr. president, following leader remarks, the senate will be in a period of morning business until 4:30 this dwraafternoon. at 4:30, the senate will proceed to executive session to consider the nomination of cornelia pillard.
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at 5:30 there will be a cloture vote on the pillard nomination. if cloture is not invoked, there will be a second roll call vote on the motion to proceed to the drug compounding bill. i'm told that s. 1661 is due for a second reading. the president pro tempore: the clerk will read the title of the bill for the second time. the clerk: a bill to require the secretary of state to offer rewards up to $5 million for information regarding the attacks on the united states diplomatic mission at benghazi, libya. mr. reid: i would object to any further proceedings with respect to this legislation. the president pro tempore: objection is heard. the bill will be placed on the calendar. mr. reid: mr. president, i extend my condolences to jim inhofe, the senior senator from oklahoma, and his wife kay on the loss of their son perry.
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the entire senate family was saddened to hear of dr. inhofe's death. he was a young man, 52 years of age, dmil killed in a plane crah early sunday. flying airplanes is in the blood of jim inhofe and his family. i really care a lot about jim inhofe. he and i are unquestionably friends. we may not agree on all political issues, but we agree that we're friends. i have had the good fortune of working to get to know this good man. i've helped him when i could. he's helped me when he can. and we put all of the disagreements to one side and look at each other for what we are outside of of our politics. i have confidence that he's going to do well. he is a man of great faith, and i feel comfortable that he will
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be able to work his way through this. madam president, my heart also goes out to the residents of the philippines who are drastically affected by this terrible, terrible storm that hit one of their -- one or two or three of their islands over the weekend. philippines is the 7,000 islands, madam president, a heavily populated area of manila was not hit, at least not very badly. we know that there are thousands of filipinos dead and missing. relief and construction efforts will be long and difficult. my thought thoughts are with the approximately 3.5 million filipinos in america today, filipino-americans living with us, including in nevada about 100,000 filipino-americans. they are involved in so many
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important things, in the health care field, business field, in the hotel business. so they are troubled -- they may not have lost family members, but they are a community that is concerned every day about what's going on. in this nation they moved from there to here, the united stat states. i was happy to hear the administration has already moved in with support, aid for this beleaguered nation. later today, madam president, we're going to attempt again to break a filibuster on the highly qualified person that has been asked by the president to serve in the d.c. circuit. it's often said that the d.c. circuit is the second-highest court in the land, after the supreme court, and that's true.
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it's unfortunate the republicans have chosen to filibuster the nomination of yet another talented female jurist and dedicated public servant to fill a vacant seat on this court. the nominee, georgetown law professor mean to that parliamentary inquiry lard has argued nine cases before the supreme court. she is briefed more than a score of cases. in one case, she argued before the supreme court, it involved a male employee of the state of nevada who was fired after taking unpaid leave to care for his wife who was sick. an important case, landmark case. the court ruled 6-3 in favor of her client, upholding important protections under the family and medical leave act. support for professor pillard's nomination is bipartisan, at least outside of the united states senate. yet senate republicans seem poised to block confirmation of
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this eminently qualified woman for a blatantly political reason -- to deny president obama his constitutional right to appoint judges. the d.c. circuit is currently operating with a really bad ratio. we have three vacancies on this very important court. for the republicans mao to claim that we don't need 11 judges is a little strange, because that isn't what they said when president bush was president, and he needed these vacancies filled. they were failed. they happily filled the nienl, tenth, and 11th seats on the d.c. circuit the same seat that president obama so aseeks to fill today, even though the court had a smaller caseload, significantly smaller caseload at the time. judge roberts was one who was appointed to the d.c. circuit
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court during protect's term. republicans have blocked two exceedingly qualified female nominees to the d.c. circuit court, hall began and patricia millett. in the last five years, five men have been confirmed to the d.c. circuit, one woman. today the senate has an opportunity to help shape a court that better reflects our country. so i hope that they will not block another qualified female nominee for partisan reasons. at least senate republicans -- the least senate republicans owe professor pillard is the same confirmation process that chief justice roberts received. should republicans block her confirmation, as i fear they will, the senate will then vote on cloture on the motion to proceed to enhance safeguards at
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compounding pharmacies, which create custom-tailored medications for patients with unique health needs. this bipartisan legislation will ensure drugs manufactured in factories and mixed in pharmacies across the country are safe for -- are really safe for consumers. the measure will also implement tracking of medicines from the factory to the drugstore itself. last year unsantory conditions at a -- unsanitary conditions led to the deaths and sickening of people. contaminated medicine was sent to 75 medical facilities in 23 states and given to 14,000 patients. the facility in yes was actually skirting existing law and acting a a large-scale manufacturing center instead of creating unique. by avoiding stricter regulations, companies like this one boost their profits by
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putting patients at rick. this legislation will end this dangerous practice and ensure drug manufacturers -- drugs manufactured and mixed in america are completely safe from the assembly line to the drugstore. this bill could pass the senate right now, but it has been stallestalled by republicans foe than a month. this legislation is truly a matter of life and death. defense authorization, madam president -- we must finish this legislation quickly so we can wrap up consideration of the crucial defense authorization bill before thanksgiving. i put senators on notice last week and the week before that we're going to do whatever it takes to accomplish exactly that, finish this bill, even if it means working this coming weekend and hopefully not the next weekend, but possibly that, too. further, we must ensure debate on the defense authorization bill is about our nation's defense and not extraneous issues. no senator should be allowed to
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jump the line and get a vote on his or her own amendment by threatening to delay action on the underlying bill. nor should the senate waste time debating amendments that are not relevant to defense. this measure ensures the safety of this nation and its dedicated service members and is more important than any one senator or any senator's parochial or political fetishes. i would note the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:
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quorum call:
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mr. mcconnell: madam president? the presiding officer: the republican leader. mr. mcconnell: are we in a quorum call? mr. mcconnell: yes, we are. mr. mcconnell: i ask further proceedings under the quorum call be dispensed with. the presiding officer: without objection. mr. mcconnell: i would like to start with a word of sympathy about the heartbreaking loss of perry inhofe, our colleague jim inhofe's son, killed in a plane crash on sunday. of course we're all thinking of jim and kay and the heartfelt prayers of the entire senate family are with them and the entire inhofe family at this very, very difficult time.
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now, madam president, despite the repeated promises of president obama, millions of people are losing their health insurance, health insurance they very much liked and were assured they could keep. it has been reported that so far 3.5 million americans have lost their health insurance under obamacare. that includes over a quarter of a million in my state of kentucky, a third of a million in florida, and almost a million people out in california. this is a serious problem that the president and congressional democrats need to do something about. the obvious answer is repeal. but in the meantime, the legislation offered by senator ron johnson would help americans keep the plans they have and like. if the president and senate democrats are serious about
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helping the millions of american who was unexpectedly lost their insurance over the past several weeks, then they should support it. unfortunately, they appear ready to ignore the problem. rather than focusing on keeping their commitment to the american people, they're focusing on things that appeal to their base. rather than change the law that is causing so many problems for so many, they want to change the subject. according to a recent report our democratic friends want to divert as much attention as possible away from the problem-plagued obamacare rollout at this formative stage of the 2014 campaign, which brings us to the vote we're going to have later today. we'll not be voting on legislation to allow americans to keep their health insurance if they like it, as they were promised again and again. rather, we'll be voting on a nominee to a court that doesn't have enough work to do, a court
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so underworked that it regularly cancels oral argument days, a court whose judges tell us that if any more judges were put on the court there wouldn't be enough work to go around, a court that is less busy now than it was when senate democrats pocket filibustered president bush's nominee to the court, peter keisler, for two whole years, two long years, and is less busy based upon the very standards that democrats themselves set forth when they blocked mr. keisler's nomination for two years. by the way, it is also less busy now than it was then, according to an analysis provided by the chief judge of the court. so, madam president, the senate ought to be spending its time dealing with a real crisis, not a manufactured one. we ought to be dealing with an ill-conceived law that is causing millions of americans to lose their health insurance. instead -- instead we'll spend
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our time today on a political exercise designed to distract the american people from the mess that is obamacare rather than trying to fix it. if our 0 democratic colleagues are going to ignore the fact that millions of people are losing their health insurance plans, they should at least be working with us to fill judicial emergencies that actually exist rather than complaining about fake ones. there are nominees on the executive calendar who would fill actual judicial emergencies. unlike the pilllard nomination, some of them in fact have been pending on the calendar longer than the pilllard nomination, but rather than work with us to schedule votes on those nominations in an orderly manner as we have been doing all year long, the majority prefers to concoct a crisis on the d.c. circuit so it can try to distract the american people from the failings of obamacare. unfortunately, our friends appear to be more concerned with playing politics than actually
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solving real problems. so i'll be voting "no" on this afternoon's political exercise. i hope the senate will focus on things the american people care about rather than spend its time trying to distract them. and finally, madam president, i'd like to congratulate archbishop joe sufficient ku -- joseph kurtz on his election as president of the u.s. council of catholic bishops. archbishop kurtz isn't a native kentuckian. he's originally from pennsylvania but we adopted him as one of our own since he was head of the louisville archdiocese in june of 2007. i wish him all the best as he seeks to promote the church's mission in the united states. congratulations. madam president, i yield the floor. the presiding officer: under the previous order, the
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leadership time is reserved. under the previous order, the senate will be in a period of morning business until 4:30 p.m. with senators permitted to speak therein for up to ten minutes each. the senator from iowa. mr. grassley: i come to the floor to speak in opposition to the motion to invoke cloture on the nomination for the d.c. circuit nominee, cornelia pilllard. although her record makes clear her views are well outside the mainstream on a host of issues, i'm not going to focus any attention on those concerns today. i'm going to focus instead on the standard the democrats established in the year 2006. based on that standard, the court's caseload makes clear that the workload simply doesn't
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justify additional judges, particularly when those additional judges cost approximately $1 million per year per judge. i've walked through these statistics several times now, and i'm not going to go in depth again. the bottom line is this, the data overwhelmingly supports the conclusion that the d.c. circuit is underworked. everyone knows this is true. that circuit does not need any more judges. now take, for instance, the appeals filed and appeals terminated. in both categories, the d.c. circuit ranks last. and in both categories, the d.c. circuit is less than half the national average. to provide some perspective on this point, compare the d.c. circuit to the 11th, after
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another judge took senior status about a week ago both the d.c. circuit and the 11th circuit have eight active judges. if we don't confirm any more judges to either court, the numbers remain the same as last year. the 11th circuit will have 875 appeals per active judge compared to the 149 appeals filed per active judge in d.c., which also has eight active judges. again, that's 875 cases for the 11th compared to 149 for d.c.. now some might argue that we shouldn't look only at active judges because those averages will change if and when we confirm more judges to the 11th circuit. suppose we fill each judgeship
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on the 11th circuit and each judgeship on the d.c. circuit as the democrats want to do. if we fill them all, there would be 583 appeals filed per judge for the 11th circuit and only 108 for the d.c. circuit. the 11th circuit then has over five times the caseload. this is why everyone who has looked at this objectively understands the caseload for the d.c. circuit is stunningly low. that is why current judges on the court have written to me and said things like this -- and i want to quote from one of the letters. quote -- "if any more judges were added now, there wouldn't be enough work to go around." end of quote. now some of my friends on the other side recognize that the d.c. circuit caseload is low,
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and they claimed then that the caseload numbers don't take into account the -- quote unquote -- complexity of the court's docket. they argue that the d.c. circuit hears more administrative appeals than other circuits do, and they claim these administrative appeals are more complex. this argument is nonsense, and i want to tell you why it's nonsense. i've heard my colleagues argue repeatedly that the d.c. circuit's docket is complex because 43% of the docket is made up of administrative appeals. but of course, that is a high percentage of a very small number. when you look at the actual number of those so-called complex cases per judge, well, the second circuit has almost twice as many as the d.c.
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circuit. in 2012 there were 512 administrative appeals filed in d.c. in circuit -- in a second circuit there were 1,493 compared to that 512. now we can look at this differently as well. there were only -- in d.c. there were only 64 administrative appeals for active judge. the second circuit has nearly twice as many per judge with 115. again that,'s 64 administrative appeals per active judge d.c. circuit as opposed to the second circuit which has almost twice as many with 115. so, this entire argument about complexity is what i already called it: nonsense.
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and the other side knows it. and if they don't know it, they ought to know. now let me raise another question regarding caseload. if these cases were really that hard, if these cases were really so complex, then why in the world would the d.c. circuit take the entire summer off? and i'm not talking about just a couple weeks in august. they don't hear any cases for the entire summer. the d.c. circuit has so few cases on their docket that they don't hear any cases from the middle of may until the second week of september. this past term the last case they heard before taking the summer off was may 16. the court didn't hear another case until september 9, four months later. the bottom line is this, everyone knows this court doesn't have enough cases as it is, let alone if we would add
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more judges. that is why when you ask the current judges for their candid assessment, they write -- and i say this again -- "if any more judges were confirmed now, there wouldn't be enough work to go around." end of quote. now, while i'm discussing the caseload issue, i want to remind my colleagues of just a little bit of history but very pertinent for this debate that's going on here. in 2006, the democrats on the judiciary committee blocked peter keisler's nomination to the d.c. circuit. they blocked mr. keisler's nomination based upon -- would you guess it? the court's caseload. since that time, by the standard set by the other side, the court's caseload has declined
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sharply. we didn't set this standard. the democrats set that standard. i recognize that the other side wants to rewrite history. they tried to compare john roberts' second nomination to the circuit, which passed fairly easily, with the current nomination. what they conveniently forget in a misleading way is that they blocked keisler's nomination after roberts' nomination. i recognize that the other side hopes that we on this side will forget that they establish these rules and these precedents. i recognize that the other side finds those rules very, very inconvenient today. but these are not reasons to ignore rules and precedents that
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they establish. there is simply no legitimate reason that the other side should not embrace those very same rules, those very same standards that they established in the year 2006, so under that standard established by the democrats in 2006, then very simply these nominations are not needed. according to the current judges themselves, these judges are not needed. according to the chief judge of the d.c. circuit who happens to be a clinton appointee, the senior judges are contributing the equivalent of an additional three and a quarter judges, so as a result the court already has the equivalent of 11 and a quarter judges, and that's way beyond -- or that is -- that is beyond even the authorized
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number. so it seems pretty clear that the other side has run out of legitimate arguments in support of these nominations. perhaps that is why then they are resorting to such cheap tactics. over the last couple days, i have heard my colleagues on the other side actually come to the floor and actually argue that republicans are opposing the nominee because of her gender. that argument is offensive, but you know, it tends to be very predictable. we have seen this before. when the other side runs out of legitimate arguments, their last library of -- line of defense is to accuse republicans of opposing nominees based upon gender or race. it's an old and it's a well-worn card, and they play it every time. the fact of the matter is -- and this is why it's offensive to
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me -- is that i voted for 75 women nominated to the bench by president obama, as well as a host of other nominees of diverse backgrounds. those are the facts, but the other side isn't concerned with facts. they are more interested in of course rhetoric and demagoguery. it's very unfortunate, those types of personal attacks on members of the senate are beneath this institution. now, given that there is no legitimate reason to fill these seats, why is the other side pushing these nominations so aggressively? and this is really the bottom line, but you can also ask why waste $3 million a year of taxpayers' money for reasons that are not legitimate, particularly in violation of the constitutional checks and
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balances. now, as to these other reasons, we don't have to guess. we know the reason. we've all heard the president pledge repeatedly if congress won't -- if congress won't act, i will. what he means, of course, is that we will rule by executive fiat. he won't go to congress. he won't negotiate. he will go around this constitutionally elected body whose constitutional powers is to make law. that's not his power. he doesn't need legislators then to enact legislation. he will just issue executive orders or issue new agency rules. why bother with us pesky senators and members of the house when you make laws with a stroke of the pen? in effect, the president is saying if the senate won't qirl
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who i want, when i want them, then i'll recess appoint them when the senate isn't even -- the senate isn't even in session. if congress won't pass cap-and-trade fee increases, then i will go around them and i will do the same thing through administrative action at the environmental protection agency. if congress won't pass gun control legislation, then i will issue executive orders. that is what the president means when he says if congress won't won't -- if congress won't act, i will. but remember, we have a system of checks and balances. under our system, when the president issues orders by executive fiat, it's the courts that provide a check on his power. it's the courts that decide whether the president is acting unconstitutionally. so the only way that the
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president's plan works is if he stacks the deck in his favor. the only way the president can successfully bypass congress is if he stacks the court with ideological allies who will rubber stamp those executive orders. this, there is no big secret here. the other side hasn't been shy about this strategy. here is how "the washington post" described this strategy -- quote -- "given liberals a greater say on the d.c. -- giving liberals a greater say on the d.c. circuit is important for obama as he looks for ways to circumvent the republican-led house and a polarized senate on a number of policy fronts through executive order and other administrative procedures." end of quote. here's another high-profile administration ally -- quote --
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"there are a few things more vital on the president's second-term agenda. with legislative priorities gridlocked in the congress, the president's best hope for advancing his agenda is through executive action, and that runs through the d.c. circuit." so the president is willing to waste $3 million of taxpayers' money a year and every year in order to bypass congress and make sure his executive orders don't lose in court. every member of this body should find that very, very troubling. finally, i want to mention a couple of points on the so-called gang of 14 agreement, which argument comes up quite frequently here on the floor even though it's going back to the 109th congress. first, by the very terms of that agreement, it applied only to those 14 senators for that
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specific congress, the 109th. second, even though that -- even though that agreement by its own terms expired at the end of the 109th congress, just last week, one of the members who was actually in the senate back in 2005 determined that these nominations in his judgment constituted extraordinary circumstances, which those two words implied that a filibuster would be justified. and third, in 2006, after the so-called gang of 14 agreement, senate democrats created a standard that we called the chrysler standard. they blocked peter keisler based on caseload after the so-called gang of 14 agreement. peter keisler waited in committee for over 900 days for
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a vote, a vote that never came. these are the rules established by the other side, and now when they are on the receiving end of those same rules, they want those rules changed. so, madam president, we don't intend to play by two sets of rules around here, and that brings me -- and that brings me the constant threat from the majority about changing the rules on the filibuster. i have been in the minority for a number of years. i have also had the privilege of serving in the majority for a number of years. many of those on the other side who are clamoring for rules change and almost falling over themselves to do it have never served a single day in the minority. all i can say is this -- be careful what you wish for.
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i have come to the conclusion that if the rules are changed, at least we republicans will get to use those new rules when we're back in the majority. republicans had the chance seven or eight years ago to change the rules, and we decided out of respect for the integrity of this institution not to change them, and i'm glad we did. i imagine we wouldn't be the first to change them in the future. remember, it was the democrats who first used the filibuster to defeat circuit judges. it was the democrats who first used the caseload argument to defeat circuit judges like peter keisler. so if the democrats are bent on changing the rules, then i say go ahead. there are a lot more scalias and thomass out there that -- thomases out there that we would love to put on the bench. the nominees we would nominate
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and confirm with 51 votes will interpret the constitution as it was written. they are not the type who would invent constitutional law right out of thin air. i urge my colleagues to oppose cloture on pillard nomination. i yield the floor. i suggest the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:
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a senator: madam president? the presiding officer: the senator from iowa. mr. harkin: i ask that further proceedings under the quorum call be dispensed with. the presiding officer: without objection. mr. harkin: first of all, madam president, i ask unanimous
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consent that nathan brown, a detailee on my staff, be granted floor privileges for the duration of the consideration of h.r. 3204, the drug quality and security act. the presiding officer: without objection. mr. harkin: and i ask unanimous consent that tatiano lowell campbell and benjamin freedman of my staff be granted floor privileges for the duration of today's session. the presiding officer: without objection. mr. harkin: madam president, i have high hopes that the senate will soon vote to enact the drug quality and security act. the so-called compounding and trace and track bill. this legislation helps ensure the safety of compounded drug products, and it also secures the pharmaceutical supply chain. i'm pleased to report that it's a product of excellent bipartisan collaboration on the health, education, labor and pensions committee where i work very closely with our ranking member, my good friend, senator lamar alexander.
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it also reflects productive conversations with our colleagues in the house, including chairman upton and ranking member waxman of the house energy and commerce committee. the house passed this bill on september 28, and now it's our turn to do our part. madam president, title 1 of the bill addresses drug compounding. and this is basically what happened here just over a year ago when we were shocked to learn one of the worst public health crises that we've experienced in recent years, a meningitis outbreak that claimed the lives of 64 americans sickened 751 people in 20 states, and you can see the hardest hit were the home state of senator alexander, 153, indiana 93, michigan, 264, virginia 54, new jersey 51,
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florida 25. 20 states. and a lot of people got really, really sick. and i'll be talking just a minute about some of those that still linger today. what this outbreak did, is it brought attention to the legal and regulatory gaps that allowed owners and managers at the new england compounding center to disregard basic procedures to ensure that the products they were manufacturing were sterile and safe. and this gross negligence had heartbreaking consequences for families nationwide. patients that were sick and patients like katrina baxter whose three adult children lost their mother and whose community lost a dedicated math teacher and tutor when she died of this meningitis outbreak at age 56. dawn elliott from indiana who used to scuba dive in her free time but is now in unrelenting
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pain, had to give up her job and deplete her savings. evelyn bates from michigan who was diagnosed last november continues to struggle with tremendous pain every day and whose daughter had to quit her job to take care of her. dennis black who lives on the west virginia-ohio border with his wife and three young children, they've had to watch their father go from being an involved parent with a steady income to a man whose daily life feels in his own words like a slow, torturous death. these meningitis outbreaks linger on. it has a kind of a personal sensitivity to me, my older brother some years ago who went deaf at a very young age because of meningitis. so it hasslingering effects for a lifetime. so that's what happened a little
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over a year ago. although we know that it wasn't just an isolated incident, it was the biggest. but this chart which is kind of hard to read shows going clear back to 2001 we've had four, 11, 64 -- in other words, every year we've had some results that we've noted from compounding, that made people sick or caused deaths. so this has been ongoing for a long time. it's just that what happened a little over year ago in tennessee and these other states was sort of the dam broke. just beyond all come comprehensn how many people got sick and died. so, again, in response to these facts beginning last year senator alexander and i convened the men's of the help committee with assistance from senators franken and senator roberts in an effort to identify the gaps
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in current policy to solicit stakeholder views, craft bipartisan legislation to better ensure the quality of compounded drug products. we formally solicited three rounds of public comment and we held two public hearings before marking up the bill last may. then over the summer we worked with our colleagues in the house to craft a package with strong bipartisan and bicameral support. now, the compounding provisions in this bill are an unqualified step forward from current law and practice. basically what this bill does in the compounding in title 1 -- we'll get to title 2 in a second -- it distinguishes compounders engaged in traditional farmers practice -- pharmacy practice from those making comownded drugs without individual prescriptions. those who wish to remain in traditional compounding that we
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might know where they're making small amounts for a certain type of illness or for a certain hospital, that type of thing, they stay under the state boards of pharmacy as they are in current law. now, an entity that neither stays within those limits of traditional pharmacy compounding nor registers as an outsourcing facility, if they don't do one of those two, then they are illegally selling unapproved drugs. so that's what it does. it distinguishes. it defines the food and drug administration's role in oversight of these outsourcing facilities. they'll be subject to f.d.a. oversight in much the same way as traditional drug manufacturers are today. f.d.a. will know who these outsources are and what they are making, adverse event reports about compounded drugs and have authority and resources to
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conduct risk-based inspections. in other words, the lines of responsibility are more clearly defined. i give much credit to my friend from tennessee for continually -- what's that will about raising the flag, who has the flag, who is responsible, because we found out it was sort of a confusing mess for everybody about who was responsible and who wasn't, and thanks to senator alexander, we have cleared that up in this bill. the bill offers providers and patients better information about compounded drugs. it directs fapped to make a list of f.d.a. regulated outsourcing facilities that will be available on their web site. requires detailed deald labeling of compounded trution, prohibits false -- drugs, and authorizes current federal law regarding the pharmacy compounding, it strikes the
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unconstitutional provisions that were in current law which kind of led to a lot of this mess. we had different courts and different parts of the country interpreting it differently. so anyway, it resolves that patchwork. applies a uniform standard nationwide. that's title 1. title 2 of the bill is the track and trace provisions. basically, this committee, again, working in a bipartisan fashion a little over a year ago, you may remember we brought an f.d.a. user bill to the floor, it passed, signed by the president, that cleared up the upstream part of where drugs come from. in other words, from initial -- from the plant derivation to the distilling of the product all the way up to the manufacturer.
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now we have a much better regulation, pictures of drugs that come from china and indonesia and u.s., no matter where they come from up to the manufacturing standpoint. what we didn't have at that time was a real understanding of or an agreement on how to control it from the manufacturer down to the consumer. so our committee got involved in this and, again, senator alexander helping to lead the way with senator bennet and senator burr. for almost two years working on this issue, and so now we have this system and i think this chart kind of shows it, as i said, everything up to the manufacturer we took care of in the f.d.a. user bill. this bill takes care of everything from the manufacturer down to the dispenser. that is down to the consumer. so no matter where the drug goes, whether it goes directly from a manufacturer to a wholesaler to a dispenser, or
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whether it goes from here to a secondary wholesaler, another secondary wholesale perks another secondary wholesaler, we found that in this country there's a patchwork, kind of an all kinds of different ways for a drug to get from a manufacturer down to a consumer. so senator burr, senator bennet, senator alexander, our staffs worked together on this to get this picture put together and to have a track and trace so that we can track the drug no matter how it goes, we can track it and we can trace it. now, that will -- that will come into being over ten years with electronic interpreamble -- interoperable tracing. you might say ten years is a long time. i would point out the house had 27 years, they agreed with us and made it 10 years but that's for electronic.
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beginning in january of 2015 there will be paper tracing. but it will take ten years to get it all at a unit level and all electronically and interoperable and you can understand it takes a long time, different splairs have different -- suppliers have different systems so this will be worked in over that period of time but we will have traceable after january of 2015. it establishes nationwide drug serial numbers, and requires a pathway to unit level tracing, as i said, strengthens license you're requirements for wholesale distributors and third-party logistics providers, and again a lot of a hodgepodge of different kind of license sures -- license you're
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licenseure and we have a nationwide serial number established for that and that will come four years after the date of enactment that will serialize drugs in a consistent way across the country. so, again, this is a bill that many might say is long overdue but better late than never. i'm sorry it took a terrible calamity like the outbreak of meningitis to get us to really focus on this and move it, but it did. and i think this is, again, a good example, again, of where the congress can work in a bipartisan, bicameral fashion. i met with chairman upton on the house side earlier this year, talking about a pathway of getting this done. in fact, what we're working on here is the house bill. the house passed it by unanimous consent. and if you've been reading much
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about the house, they don't do much by unanimous consent in the house. that just shows you how much work went into the bill and how it was done in a true bipartisan, bicameral fashion. so the house passed it by unanimous consent, and now we have it here and i dare say but for a senator, one person, we probably would have passed it by unanimous consent here. i haven't found anyone that's opposed to this bill and who doesn't recognize that it's well supported. we have a plethora of people and industry and consumer support. american farm assists association, public health association, biotechnology industrial organization, plus a lot of the big pharmaceutical manufacturers, some of the small pharmaceutical manufacturers. everyone recognizes that we need
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a better system to clearly outline who the traditional compounders are and who the outsources are, give f.d.a. clear-cut authority over one segment, give the states a clear-cut authority over the other segment. if you don't fall in one of those two, you're outside the law. so it really does clear it up, and this will ensure the quality and safety of the drugs that patients rely on. i'm hopeful that we have a cloture vote later today, i'm hopeful we'll have a good strong vote on cloture on this bill. as i said, i can honestly say standing here i have not heard one senator from either side of the aisle tell me or inform my staff they're opposed to the bill as such to the bill. i hope we have a strong vote and i'm going to yield the floor and, again, pay my compliments
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and my highest respect to senator alexander for his leadership on this, his state was hit very hard by this. i know he's very sensitive to that and i know that -- just from my talks with him i know that it pained him a great deal to see so much suffering and deaths in his own state and senator alexander got on top of this and pulled us all together and basically said we got to get it done. so senator alexander, thank you very much. i yield the floor. the presiding officer: the senator from tennessee. mr. alexander: on behalf of the people of tennessee that i represent and i think the american people as well, i want to thank the senator from iowa for his leadership on these two bills but particularly on the compounding pharmacy bill. our differences of opinion in the united states senate are well advertised on obamacare, on debt, on syria, a whole vartd of matters. you would say the reason we exist is to debate the bill issues that -- big issues that haven't been resolved somewhere
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else. but there's another aspect of the senate as rarely well advertised and that's when we get a result. and sometimes the results take a long time, involve a lot of people and are very difficult to get to and that is the case with these two bills and had not senator harkin been patient and as well as aggressive at the same time, in working with republicans and democrats, with members of the house we would not have gotten to today. i think it's important to call to the attention of the american people this result, because these two pieces of legislation, one which makes it clear who is in charge as senator harkin said, who's on the flagpole, when it comes to making sure that the sterile drugs that are injected into your back, when you have back pain, are safe so that you don't end up with a horrible death from fungal meningitis, who's responsible for that and the second bill is how are we going to make s


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